Job Description:

Must have: CMC, Drug Development, Process Validation

Job Summary:

The Process Validation Project Coordinator role will provide support to Technical Development Teams (TDTs) on Process Validation (PV) including project and portfolio analyses and communication of key insights to inform decision-making. He/She/They will work closely with PV stakeholders to plan, maintain, and manage all PV deliverables. The role will be in the Pharma Technical Development Project and Portfolio Management (PTDM).

Job Responsibilities:

• Support the TDTs and ensure on-time Market Applications (MAs) by developing and maintaining PV project schedules and dashboards to track progress.

• Apply drug/CMC process development knowledge and project management expertise to manage PV deliverables for multiple projects through MA filing and Pre-Licensure Inspection (PLI).

• Lead regular meetings with PV leads to ensure PV studies are on track and keep all relevant stakeholders including the Technical Development Leader (TDL) updated on PV project status, key risks, and issues.

• Provide expertise and guidance to TDTs on PV at project level including continuous improvement of business processes and tools analyses and communication of key portfolio insights to inform decision-making.

• Act as a valuable member of the overall project team system (e.g., shares best practices and lessons learned).

Job Requirements/ Qualifications:

• BS/BA degree in the scientific field

• 2+ years in the pharmaceutical/biotech industry

• 2+ years of drug development project management and process validation experience is preferred

• Experience and knowledge with Smartsheet, Tableau, and other reporting and tracking tools

Knowledge/Skills/Competencies:

• Knowledge of the drug development process

• Knowledge and experience with end-to-end CMC process development; relevant process validation, regulatory, quality, and cGMP expertise is preferred

• Ability to manage cross-functional teams and development projects and to apply project management skills, methodologies, and tools

• Strong collaborative and relationship-building skills; demonstrated ability to effectively partner and influence internal and external stakeholders

• Excellent verbal and written communication skills; must be able to effectively communicate/articulate strategy and deliverables to team members and senior management

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.